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Trial History Detail on 2011-02-08

CUHK_CCT00136

2007-08-14

Prospective

nil

Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong

nil

nil

Dr Chan Shing Chee, Symphorosa

Dept of O&G, PWH

Tel: 2632 2583,

email: symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

Dr Chan Shing Chee, Symphorosa

Dept of O&G, PWH

Tel: 2632 2583,

email: symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

A Randomized, Crossover Study of Medroxyprogesterone Acetate and Diane-35 on Polycystic Ovarian Syndrome Adolescents

A Randomized, Crossover Study of Medroxyprogesterone Acetate and Diane-35 on Polycystic Ovarian Syndrome Adolescents

A Randomized, Crossover Study of MPA and Diane-35 on PCOS Adolescents

Hong Kong

Yes

2007-05-04

Polycystic Ovarian Syndrome

Drug

Group 1 will receive oral (medroxyprogesterone acetate) MPA 10 mg daily for 10 days for every month for the first 4 months, followed by a washout period of 4 months, and then diane-35 one tablet daily for 21 days for every month for another 4 months. Group 2 will receive the same combination but in reverse order.

4 months treatment, 4 months washout & 4 months treatment

Group 1 will receive oral (medroxyprogesterone acetate) MPA 10 mg daily for 10 days for every month for the first 4 months, followed by a washout period of 4 months, and then diane-35 one tablet daily for 21 days for every month for another 4 months. Group 2 will receive the same combination but in reverse order.

Inclusion criteria: Patients aged 14 to 19 and diagnosed PCOS in the Gynaecology clinics of AHNH and PWH. The diagnosis of PCOS is based on the Rotterdam consensus on diagnostic criteria for PCOS; that is, at least 2 out of 3 of the following criteria: 1) Oligo- and / or anovulation; 2) Clinical and / or biochemical signs of hyperandrogenism; 3) Ultrasound appearance of polycystic ovaries; and exclusion of other aetiologies.

Exclusion criteria are: 1) patient who has fertility wish; 2) confirmed concomitant diabetics mellitus which may need other medical treatment for PCOS; 3) significant liver impairment or other medical condition that is contraindicated for MPA or diane-35; and 4) previous use of hormonal treatment in the past 4 months.

14

19

Female

Interventional

Randomized

Active

Open label

Crossover

2007-08-22

100

Recruiting

The primary outcome measure is the psychological well being of the subjects on the different treatments, using a standard questionnaire 36-item Short Form Health Survey (SF-36) and a client satisfaction questionnaire. They will be assessed during every visit (ie at baseline, 4 month, 8 month & 12 month of study)

All of the following will be assessed or measured during every visit (ie at baseline, 4 month, 8 month & 12 month of study) 1. Menstrual pattern and any abnormal bleeding throughout the study period. 2. Clinical parameters including body mass index, blood pressure, waist-to-hip circumference ratio, scoring on acne and hirsutism. 3. Hormonal profile by measurements of serum concentrations of luteinizing hormone, follicular stimulating hormone, oestradiol, testosterone, sex hormone binding globulin, and androstenedione.

No

2011-03-03

ChiCTR-TRC-09000699

2010-05-04


Yes

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